Reported May 4, 2022 · Ongoing
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
IMMULITE 2000 Systems HCG [200 Testsmaterial number 10381206catalog number L2KCG] and [600 Testsmaterial number 10381194catalog number L2KCG6]
- Lot codes and dates
- 8
- production lots
463464466467469470471472[UDI
- for 200 tests
(01)00630414961132(10)463(17)20220228(01)00630414961132(10)464(17)20220331(01)00630414961132(10)466(17)20220331(01)00630414961132(10)467(17)20220531(01)00630414961132(10)469(17)20220731(01)00630414961132(10)470(17)20220930(01)00630414961132(10)471(17)20221130(01)00630414961132(10)472(17)20230228] [UDI
- for 600 tests
(01)00630414961149(10)463(17)2022022801)00630414961149(10)464(17)20220331(01)00630414961149(10)466(17)20220331(01)00630414961149(10)467(17)20220531(01)00630414961149(10)469(17)20220731(01)00630414961149(10)470(17)20220930(01)00630414961149(10)471(17)20221130(01)00630414961149(10)472(17)20230228]
- Amount recalled
- 10,755 boxes (533 US, 10,222 OUS)
Where it was sold
Why it was recalled
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
This product could cause temporary or reversible health problems — stop using it.
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